Pilot QC Engineer II: Manufacturing & Process Improvement

Edwards Lifesciences; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences in California is seeking a Pilot Operations Quality Engineer II to drive quality operations for pilot manufacturing and to lead compliance activities across the product lifecycle. The role focuses on implementing quality systems and processes to ensure patient safety and regulatory compliance.

The position collaborates with TMTT and development teams to produce test samples, support feasibility studies and early human use, and manage product transfers to receiving

Qualifications

• Requires a Bachelor’s degree in an engineering field plus 2+ years medical device experience.
• Master’s degree in engineering plus 1 year medical device experience.

Responsibilities

• Interact with multiple departments to achieve quality goals focused on Pilot manufacturing operations.
• Support new product development teams to navigate Edwards’ Quality System for test samples and human-use products.
• Review and approve equipment validations and asset management actions.
• Lead process improvements using SIX Sigma, TOPP and LEAN methods to reduce risk and improve manufacturing.
• Develop training and documentation for production to enable knowledge transfer.
• Perform risk assessments on early-stage manufacturing processes and drive improvements.
• Lead test method validation activities for in-process inspections and oversee product release.

Skills

Quality system knowledge

Problem solving

Data analysis

CAPA handling

Risk assessment

Training documentation

Cross-functional teamwork

Manufacturing process optimization

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Tools

MES

Job description

Edwards Lifesciences in California is seeking a Pilot Operations Quality Engineer II to drive quality operations for pilot manufacturing and to lead compliance activities across the product lifecycle. The role focuses on implementing quality systems and processes to ensure patient safety and regulatory compliance.

The position collaborates with TMTT and development teams to produce test samples, support feasibility studies and early human use, and manage product transfers to receiving